UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
For the month of January 2026
Commission File Number: 001-37643
PURPLE BIOTECH LTD.
(Translation of registrant’s name into English)
4 Oppenheimer Street, Science Park, Rehovot
7670104, Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual
reports under cover Form 20-F or Form 40-F.
Form 20-F ☒
Form 40-F ☐
On January 7, 2026, Purple Biotech Ltd. (the “Registrant”)
issued a press release “Purple Biotech Achieves Toxicology Milestone Demonstrating an Expanded Therapeutic Window for CAPTN-3
Platform Tri-specific Antibody, IM1240”, which is attached hereto as Exhibit 99.1.
| Exhibit |
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| 99.1 |
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Purple Biotech Achieves Toxicology Milestone Demonstrating an Expanded Therapeutic Window for CAPTN-3 Platform Tri-specific Antibody, IM1240 |
Incorporation by Reference
This Report on Form 6-K,
including all exhibits attached hereto, is hereby incorporated by reference into each of the Registrant’s Registration Statement
on Form S-8 filed with the Securities and
Exchange Commission on May 20, 2016 (Registration file number 333-211478), the Registrant’s Registration Statement on Form
S-8 filed with the Securities and Exchange Commission on June 6, 2017 (Registration file number 333-218538), the Registrant’s
Registration Statement on Form F-3,
as amended, originally filed with the Securities and Exchange Commission on July 16, 2018 (Registration file number 333-226195), the Registrant’s
Registration Statement on Form
S-8 filed with the Securities and Exchange Commission on March 28, 2019 (Registration file number 333-230584), the Registrant’s
Registration Statement on Form F-3
filed with the Securities and Exchange Commission on September 16, 2019 (Registration file number 333-233795), the Registrant’s
Registration Statement on Form
F-3 filed with the Securities and Exchange Commission on May 13, 2020 (Registration file number 333-238229), the Registrant’s
Registration Statement on Form
S-8 filed with the Securities and Exchange Commission on May 18, 2020 (Registration file number 333-238481), each of the Registrant’s
Registration Statements on Form F-3 filed with the Securities and Exchange Commission on July 10, 2020 (Registration file numbers 333-239807
and 333-233793), the Registrant’s
Registration Statement on Form
S-8 filed with the Securities and Exchange Commission on April 4, 2022 (Registration file number 333-264107), the Registrant’s
Registration Statement on Form
F-3, as amended, originally filed with the Securities and Exchange Commission on December 8, 2022 (Registration file number 333-268710),
and the Registrant’s Registration Statement on Form
F-3 filed with the Securities and Exchange Commission on March 23, 2023 (Registration file number 333-270769), to be a part thereof
from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
| January 7, 2026 |
PURPLE BIOTECH LTD. |
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By: |
/s/ Gil Ef ron |
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Gil Efron |
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Chief Executive Officer |
Exhibit 99.1
Purple Biotech Achieves Toxicology Milestone
Demonstrating an Expanded Therapeutic Window for CAPTN-3 Platform Tri-specific Antibody, IM1240
IM1240 demonstrated
improved safety in a toxicology study at doses up to 300-fold higher than a non-capped comparator
IM1240’s pharmacokinetic
profile showed increased systemic exposure and a prolonged circulating half-life enabled by its human serum albumin moiety and capping
design
IM1240 on track towards
first-in-human clinical trials, with regulatory submission planned for the second half of 2026
REHOVOT, Israel, Jan. 07, 2026 (GLOBE
NEWSWIRE) -- Purple Biotech Ltd. (“Purple Biotech” or the “Company”) (NASDAQ/TASE: PPBT), a clinical-stage
company developing a next-generation immunotherapy platform designed to maximize anti-cancer potency while minimizing toxicity,
today announced successful completion of a non-human primates toxicology study (the “Study”) of IM1240, a tri-specific
antibody from its CAPTN-3 platform that targets 5T4, a tumor-specific antigen expressed on multiple solid tumors.
The Study demonstrated that IM1240’s proprietary
capping technology enabled dosing at levels up to 300-fold higher than a non-capped comparator, with significantly reduced immune-related
toxicity, including minimal cytokine release. These results highlight the unique safety profile of this approach, which may address a
key limitation of certain current T cell engagers, where cytokine release syndrome can restrict dosing.
“In the Study, IM1240 demonstrated a
favorable safety and tolerability profile, with hematologic findings that align with its expected pharmacodynamic effects on immune activation.
The CD3 capping design of IM1240 showed clear differentiation compared with the non-capped comparator, IM1222, enabling a significant
reduction in immune-related effects, including cytokine release, which remained modest, even at doses up to 300-fold higher than those
of the non-capped antibody,” stated Gil Efron, CEO of Purple Biotech. “Purple Biotech continues to deliver on its stated milestones
and we believe that collectively, these data provide translational guidance that may inform optimal dose selection, dosing strategy, and
safety monitoring plans for the next phase of advanced toxicological assessments. We are working to advance IM1240 toward first-in-human
studies as efficiently as possible and expect to provide updates on our progress over the course of 2026.”
IM1240 demonstrated a favorable pharmacokinetic
(PK) profile in the Study, characterized by increased systemic exposure and a prolonged circulating half-life. PK analyses showed dose-dependent
and proportional increases in exposure, as reflected by both AUC and Cmax. The Company believes these findings support dose-exposure
relationship and provide proof of concept for the capping design and albumin incorporation as a contributor to IM1240’s favorable
PK profile. In addition, efficacy observed in vivo in tumor-bearing mice occurred at exposures meaningfully lower than
those achieved in the Study, further supporting IM1240’s advantageous therapeutic window.
About the CAPTN-3 Platform
CAPTN-3, Purple Biotech’s lead program, is
a platform of capped tri-specific antibodies that simultaneously target tumor-associated antigens while engaging both T cells and NK cells.
Proprietary capping technology confines immune activation to the tumor microenvironment by masking the CD3-binding arm in circulation
and activating it only at the tumor site, significantly expanding the therapeutic window versus conventional T-cell engagers. The platform’s
lead candidates, IM1240 (targeting 5T4) and IM1305 (targeting TROP2), are in preclinical development.
About Purple Biotech
Purple Biotech Ltd. (NASDAQ/TASE: PPBT) is
a clinical-stage oncology company developing first-in-class therapies to overcome tumor immune evasion and drug resistance. The Company
is focused on advancing its lead program, CAPTN-3 - a platform of capped tri-specific antibodies that simultaneously target tumors while
engaging both T cells and NK cells. Proprietary capping technology confines immune activation to the tumor microenvironment, significantly
expanding the therapeutic window versus conventional T-cell engagers. The platform’s lead candidate, IM1240 is advancing toward
the clinic and IM1305 is in preclinical development. The Company’s pipeline also includes additional clinical-stage assets, including
CM24, a CEACAM1-blocking antibody that demonstrated improved outcomes across all efficacy endpoints in a Phase 2 study for the treatment
of pancreatic ductal adenocarcinoma, and NT219, a dual IRS1/2 and STAT3 inhibitor in a Phase 2 study for the treatment of recurrent and/or
metastatic squamous cell carcinoma of the head and neck. The Company is headquartered in Rehovot, Israel. For additional information
about the Company, please visit: https://purple-biotech.com
Forward-Looking Statements and Safe Harbor Statement
Certain statements in this press release that
are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions
of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements that
are not statements of historical fact, and may be identified by words such as “believe”, “expect”, “intend”,
“plan”, “may”, “should”, “could”, “might”, “seek”, “target”,
“will”, “project”, “suggest”, “forecast”, “continue” or “anticipate”
or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly
to historical matters. You should not place undue reliance on these forward-looking statements, which are not guarantees of future performance.
Forward-looking statements reflect our current views, expectations, beliefs or intentions with respect to future events, and are subject
to a number of assumptions, involve known and unknown risks, many of which are beyond our control, as well as uncertainties and other
factors that may cause our actual results, performance or achievements to be significantly different from any future results, performance
or achievements expressed or implied by the forward-looking statements. Important factors that could cause or contribute to such differences
include, among others, risks relating to: the plans, strategies and objectives of management for future operations; product development
for NT219, CM24 and CAPTN-3; the process by which such early stage therapeutic candidates could potentially lead to an approved drug product
is long and subject to highly significant risks, particularly with respect to a joint development collaboration; the fact that drug development
and commercialization involves a lengthy and expensive process with uncertain outcomes; our ability to successfully develop and commercialize
our pharmaceutical products; the expense, length, progress and results of any clinical trials; the impact of any changes in regulation
and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals necessary in order
to commercialize our products; the difficulty of predicting actions of the U.S. Food and Drug Administration or any other applicable regulator
of pharmaceutical products; the regulatory environment and changes in the health policies and regimes in the countries in which we operate;
the uncertainty surrounding the actual market reception to our pharmaceutical products once cleared for marketing in a particular market;
the introduction of competing products; patents obtained by competitors; dependence on the effectiveness of our patents and other protections
for innovative products; our ability to obtain, maintain and defend issued patents; the commencement of any patent interference or infringement
action against our patents, and our ability to prevail, obtain a favorable decision or recover damages in any such action; and the exposure
to litigation, including patent litigation, and/or regulatory actions, and other factors that are discussed in our Annual Report on Form
20-F for the year ended December 31, 2024 and in our other filings with the U.S. Securities and Exchange Commission (“SEC”),
including our cautionary discussion of risks and uncertainties under “Risk Factors” in our Registration Statements and Annual
Reports. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides
those we have listed could also adversely affect us. Any forward-looking statement in this press release speaks only as of the date on
which it is made. We disclaim any intention or obligation to publicly update or revise any forward-looking statement or other information
contained herein, whether as a result of new information, future events or otherwise, except as required by applicable law. You are advised,
however, to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC’s website, https://www.sec.gov.
CONTACTS:
Company Contact:
IR@purple-biotech.com
